European Commission 28 May 2014, Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use Text with EEA relevance

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European Union · · · Cited by 46 · 28-05-2014

Article 1. Scope
Article 2. Definitions
Article 3. Quality management
Article 4. Personnel
Article 5. Buildings and facilities
Article 6. Equipment
Article 7. Documentation and records
Article 8. Material management
Article 9. Production and in-process control
Article 10. Packaging and labelling
Article 11. Placing on the market
Article 12. Laboratory controls
Article 13. Validation
Article 14. Change control
Article 15. Rejection and returns
Article 16. Complaints and recalls
Article 17. Contract manufacturing
Article 18. Repackaging
Article 19. Entry into force

25.11.2014

Official Journal of the European Union

L 337/1

COMMISSION DELEGATED REGULATION (EU) No 1252/2014

of 28 May 2014

supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use

(Text with EEA relevance)

THE EUROPEAN

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